YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 302 drug applications between 27 June 2025 and 3 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 46 drug names.
2025/06/27 – 2025/07/03
- New acceptances this week
- 302
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 48
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
302filings, 67 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 181 |
| Generic | 67 |
| New drug | 36 |
| Import re-registration | 11 |
| Import | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 171 |
| TCM | 95 |
| Therapeutic biologic | 35 |
| Prophylactic biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 6 | 6 | 53 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 4 | 4 | 53 |
| 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 4 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 5 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 6 | Cefazolin Sodium for Injection | 3 | 1 | 13 |
| 7 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 8 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 9 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 10 | Cilostazol Orally Disintegrating Tablets | 2 | 1 | 2 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
183 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Pfizer Australia Pty Ltd | 7 | 2 | 0 |
| 4 | Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 5 | 0 |
| 6 | Lanzhou Tai Bao Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 7 | Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Topfond Pharmaceutical Co., Ltd. | 5 | 4 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 10 | Celgene Corporation | 5 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/03Generic · Class 3 | Peramivir InjectionCYHS2502356 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | 注射用泮托拉唑钠(Ⅰ) · No verified English nameCYHS2502352 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2502351 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/07/03Generic · Class 3 | Multiple Vitamins InjectionCYHS2502350 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | Atropine Sulfate InjectionCYHS2502347 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | Cilostazol Orally Disintegrating TabletsCYHS2502346 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | Cilostazol Orally Disintegrating TabletsCYHS2502345 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | Cefazolin Sodium for InjectionCYHS2502344 | Chi Feng Wan Ze Pharma Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | Cefazolin Sodium for InjectionCYHS2502343 | Chi Feng Wan Ze Pharma Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | Cefazolin Sodium for InjectionCYHS2502342 | Chi Feng Wan Ze Pharma Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2025/07/03New drug · Class 2.3 | 小儿肺热咳喘颗粒 · No verified English nameCXZL2500043 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2025/07/03New drug · Class 1 | 注射用SIM0609 · No verified English nameCXSL2500534 | Shanghai Xian Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/03New drug · Class 1 | SHR-3045注射液 · No verified English nameCXSL2500533 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/07/03New drug · Class 2.2 | HECB2100401吸入喷雾剂 · No verified English nameCXHL2500636 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2025/07/03New drug · Class 1 | CB03-154片 · No verified English nameCXHL2500635 | Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/03New drug · Class 1 | GFH276片 · No verified English nameCXHL2500634 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/07/03New drug · Class 1 | GFH276片 · No verified English nameCXHL2500633 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/07/02Import · Class 1 | AB248 (etakafusp alfa) 注射液 · No verified English nameJXSL2500116 | Asher Biotherapeutics Inc.; PAREXEL CHINA CO. LTD |
| 2025/07/02Import · Class 1 | AZD2936 · No verified English nameJXSL2500115 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/02Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2502341 | Sichuan Jian Lin Pharma Co., Ltd. romanized; Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2025/07/02Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2502338 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/07/02Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2502334 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2025/07/02Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2502333 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/07/02Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502332 | Guo Yue (Shandong) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/07/02Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502331 | Guo Yue (Shandong) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/07/02New drug · Class 1 | 个性化树突状细胞注射液 · No verified English nameCXSL2500532 | Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized |
| 2025/07/02New drug · Class 1 | 个性化树突状细胞注射液 · No verified English nameCXSL2500531 | Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized |
| 2025/07/02New drug · Class 1 | 个性化树突状细胞注射液 · No verified English nameCXSL2500530 | Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized |
| 2025/07/02New drug · Class 1 | BBT002注射液 · No verified English nameCXSL2500529 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/02New drug · Class 1 | BBT002注射液 · No verified English nameCXSL2500528 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
38 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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